10 mg vaginal insert
dinoprostone
What Propess is and what it is used for
Propess contains the active substance dinoprostone 10 mg which is used to start labor after 37 full weeks of pregnancy. Dinoprostone causes the birth canal (cervix) to mature and open so that childbirth can take place. There can be several reasons why you want to start labor. Ask your doctor if you want to know more.
What you need to know before you receive Propess
Propess is not given
- if the size of the fetal head can cause problems during childbirth
- if the position of the fetus in the uterus does not allow natural ( vaginal ) delivery
- if the fetus shows signs of not feeling well and/or is negatively affected
- if you have previously undergone major surgery or had a ruptured cervix
- if you have an untreated infection/inflammation in the small pelvis (in the uterus, ovaries, fallopian tubes, and/or cervix)
- if the placenta lies as an obstruction in the birth canal
- if you have or have had any unexplained vaginal bleeding during your current pregnancy
- if you have had surgery previously in the womb, including previous caesareans
- if you are allergic to dinoprostone or any of the other ingredients of Propess (listed in section 6)
Your doctor or nurse will not give you Propess or will remove it after it has been given to you:
- when the birth has started
- if drugs with oxytocin effect need to be administered to assist with labor
- if you have too strong or prolonged contractions in the uterus
- if the fetus shows signs of not feeling well
- if you get side effects (see section 4. Possible side effects ).
There is limited experience with the use of Propess after the amniotic fluid has passed. If the amniotic fluid is flowing or you are planning to pierce the amniotic membranes, your doctor or nurse will remove Propess.
Warnings and cautions
Before you are given Propess, tell your doctor or nurse if any of the following apply to you:
- if you have or have had asthma (difficulty breathing) or glaucoma (an eye disease)
- if you have previously given birth with too strong or too prolonged contractions
- if you have any lung, liver, or kidney disease
- if you are expecting more than one child
- if you have had more than 3 vaginal births
- if you are using painkillers or anti-inflammatory drugs that contain NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin
- if you are 35 years or older, if you have a pregnancy complication in the form of, for example, diabetes, high blood pressure, or too low metabolic hormones ( hypothyroidism ), or if the duration of pregnancy has exceeded 40 weeks, there is an increased risk of developing disseminated intravascular coagulation ( DIC ), an unusual condition that affects blood coagulation.
Children and young people
The use of Propess in pregnant women under 18 years of age has not been studied.
Other medicines and Propess
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Propess can make you extra sensitive to a class of drugs called oxytocin drugs which are used to enhance contractions. It is not appropriate to administer these medicines together with Propess.
Pregnancy and breastfeeding
Propess is used to start labor. Propess should not be used at any other time during pregnancy.
The use of Propess during breastfeeding has not been studied. Propess can be excreted in breast milk, but the amount and duration are expected to be very limited and should not prevent breastfeeding. No effects on the newborn have been observed.
Driving and using machines
Not relevant as Propess is only given in connection with childbirth.
How Propess is given to you
Propess will be given to you by trained care staff in a hospital or clinic where there is access to the supervision of you and your child.
The doctor or nurse applies a vaginal insert high up in the posterior fornix (next to the cervix) of the vagina. You should not do this yourself. To facilitate insertion, the doctor or nurse will place the vaginal insert using only a small amount of water-soluble lubricant. A sufficiently long piece of tape attached to the insert will be left outside the vagina to facilitate removal when it is time for this.
You should lie back during the actual insertion and for another 20-30 minutes after the insertion.
When the vaginal insert has been applied in the correct position, it will absorb some of the fluid that is in the environment. This allows dinoprostone to be released slowly.
While the vaginal insert is in place to start the labor, you will be checked regularly, among other things about:
- the degree of opening of your cervix
- uterine contractions
- labor pains and how the baby is feeling.
The doctor or nurse decides how long Propess needs to stay, depending on how the birth progresses. Propess can remain for a maximum of 24 hours.
When the preparation is taken out of the vagina, it has swelled to 2-3 times its original size and it is soft.
If you have been taking Propess for a longer period than you should
If you have received Propess for a longer period than you should, it can lead to increased uterine contractions or the fetus feeling unwell. In these cases, the Propes vaginal insert should be removed immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
- Increased uterine contractions that can affect the fetus
- The fetus may be adversely affected and/or its heart rate faster or slower than normal
- Discolored amniotic fluid.
Uncommon (may affect up to 1 in 100 people)
- Headache
- Lowered blood pressure
- The newborn baby has difficulty breathing right after birth
- The newborn baby has high levels of bilirubin in the blood, a breakdown product of red blood cells that can lead to yellowing of the skin and eyes.
- Itching
- Heavy vaginal bleeding after childbirth
- The placenta detaches from the uterine wall before the baby is born
- The decreased general condition of the newborn just after birth
- Slowly progressing labor
- Inflammation of the uterine lining
- The maternal uterus does not contract after delivery due to a lack of normal uterine contractions
- Burning sensation in the abdomen
- Fever.
Has been reported (occurs in an unknown number of users)
- Fetal death, stillbirth, and death of the newborn ( neonatal death); especially after serious events such as rupture of the uterus.
- Disseminated intravascular coagulation ( DIC ), is a rare coagulation effect that affects the blood’s ability to coagulate (coagulate). This can cause blood clots to form and may increase the risk of bleeding.
- The fluid that surrounds the baby during pregnancy can enter the mother’s bloodstream during childbirth and block blood vessels. This can lead to a condition called amniotic fluid embolism which can include the following symptoms: shortness of breath, low blood pressure, anxiety and chills, life-threatening problems with blood clots, seizures, coma, blood and fluid in the lungs, and fetal distress such as low heart rate.
- Hypersensitivity reactions and severe allergic reactions ( anaphylactic reactions) may include difficulty breathing, shortness of breath, weakened or increased heart rate, dizziness, reddening of the skin, and rash.
- Stomach pain
- Nausea
- Vomiting
- Diarrhea
- Swelling of the abdomen
- Rupture of the uterus.
How to store Propess
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the aluminum bag and the carton after “EXP”. The expiration date is the last day of the specified month.
Store in a frozen state (-10 to -25 ° C). Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. After use, the doctor or nurse will dispose of the entire vaginal insert as clinical waste. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is dinoprostone, better known as prostaglandin E 2 . Each post contains 10 mg of dinoprostone which is released at approximately 0.3 mg per hour for 24 hours.
- The other ingredients are cross-linked macrogol (hydrogel) and polyester thread.
What the medicine looks like and the contents of the pack
The vaginal insert consists of a small rectangular insert in plastic material enclosed in a polyester reservoir system. The plastic material consists of a hydrogel polymer that swells in the presence of liquid, which enables the release of dinoprostone. The insert is provided with a long strap so that the doctor or nurse can remove it when needed.
Each vaginal insert is individually packaged in a sealed foil bag made of aluminum/polyethylene laminate and is packaged in a carton.
The package contains 5 vaginal inserts.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
SE-203 11 Malmö
Tel. 040-691 69 00
Manufacturer
Ferring GmbH
Wittland 11
24109 Kiel
Germany